ASIS for Botox in Chronic Migraine (ASISinCM)
June 22, 2015 updated by: ASIS Corporation
Botox acts on nerve endings, yet there are no nerve endings inside the muscle, where they are typically injected.
All nerves terminate on the fascia, where ASIS device can precisely deliver Botox by creating that subdermal bloodless space, between the skin and muscle.
Thus enhancing and prolonging Botox's efficacy, at the same time prevent it's unnecessary adverse reactions and distant spread, especially since Botox has no reason to travel to the rest of the body any way.
Study Overview
Status
Unknown
Intervention / Treatment
- Drug: Gadolinium
- Drug: Gadolinium
- Drug: Efficacy of Botox intramuscularly at Week 6
- Drug: Efficacy of Botox intramuscularly at Week 12
- Drug: Efficacy of Botox intramuscularly at Week 18
- Drug: Efficacy of Botox intramuscularly at Week 24,
- Drug: Efficacy of Botox intramuscularly at Week 30
- Drug: Efficacy of Botox subdermally at Week 6
- Drug: Efficacy of Botox subdermally at Week 12
- Drug: Efficacy of Botox subdermally at Week 18
- Drug: Efficacy of Botox subdermally at Week 24
- Drug: Efficacy of Botox subdermally at Week 30
- Drug: Adverse Reactions of Botox intramuscularly
- Drug: Adverse Reactions of Botox subdermally
Detailed Description
Aim 1 over 6 months will demonstrate ASIS device's consistent performance on 60 adult subjects with Chronic Migraine (≥15 days per month, with headache lasting 4 hours a day or longer). Gadolinium will be injected with ASIS subdermally (30) or conventional intramuscularly (30) for these 6 muscle groups: Glabella, Frontal, Temporal, Occipital, Paraspinal, and Trapezius. An MRI will be taken promptly after Gadolinium injection, as starting reference, to which subsequent MRI taken at 6 hrs, 12 hrs, and 24 hrs later will be compared for Persistent %. Since there isn't a way to measure level of Gadolinium within it, or any other (e.g. Botox) for that matter, at least the Prolongation of Gadolinium may be approximated by the greater or longer Persistent % on MRI. However, this approximation can only work if the variables are minimized to the same population with Chronic Migraine, and these particular 6 muscle groups. Case in point, patients with Chronic Migraine presumably have hyperactive Glabella, Frontal, Temporal, Occipital, Paraspinal, and Trapezius muscles, so expectantly will have shortened Gadolinium intramuscularly Persistent %, and somewhat Gadolinium subdermally Persistent % as well due to agitation, thus these Persistent % values in Chronic Migraine patients will not be like those of normal patients, or even the same between these 6 different muscle groups. Therefore, the Relative Prolongation Ability Score or total Persistent % subdermally over total Persistent % intramuscularly, will be specific and valuable indicators to help us modify the Botox dosage and duration to inject into that "unknown" subdermal bloodless space for Aim 2.
Aim 2 over 12 months, using Botox, instead of Gadolinium, to demonstrate the advantages of ASIS device subdermally over intramuscularly, for the particular 6 muscle groups on the same 60 Chronic Migraine adults. Given that there isn't a way to detect Botox in the peripheral blood to document Prolongation of Botox Pharmacokinetically, this Relative Prolongation Ability is our best and only possible way to demonstrate that subdermal bloodless space's ability on Botox. Although valuable, that Relative Prolongation Ability Score from Aim 1 isn't absolutely required to start Aim 2. Hypothetically speaking, if that subdermal bloodless space in patients with e.g., Chronic Migraine somehow failed to show prolongation of half-life for Gadolinium in Aim 1, we can still proceed with primary interest being therapeutic comparison for Botox in Aim 2, in terms of reduction in Number of Headache Days from Baseline, and adverse reactions.
Study Type
Interventional
Enrollment (Anticipated)
60
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Westminster, California, United States, 92683
- Automatic Subdermal Injector System, Inc
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Must have history of chronic migraine (with or without aura) according to the criteria proposed by the Headache Classification Committee of the International Headache Society for at least 3 months prior to enrollment.
- Must be able to understand the requirements of the study including maintaining a headache diary, and signing informed consent.
- If taking migraine preventive, must be on a stable dose of preventive medication for at least 3 months.
Exclusion Criteria:
- Has headache disorders outside IHS-defined chronic migraine definition.
- Has evidence of underlying pathology contributing to their headaches.
- Has any pathology of the salivary glands such as sialadenitis (e.g. Sjogren's syndrome, viral or bacterial sialadenitis) or condition or symptom that would alter the content of saliva.
- Has any medical condition that may increase their risk with exposure to Botox including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other significant disease that might interfere with neuromuscular function.
- Has profound atrophy or weakness of muscles in the target areas of injection.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Glabella
Glabella Gadolinium Magnevist® (gadopentetate dimeglumine) .1cc/ diluted with .9ccNS intramuscularly for 30 patients, and subdermally with ASIS Device for 30 patients. |
Gadolinium .1cc/
diluted with .9ccNS
intramuscularly with ASIS Device for 30 patients.
Total cumulative Persistent % of Gadolinium intramuscularly on MRI at 6 hrs, 12 hrs, and 24 hrs.
Other Names:
Relative Prolongation Ability Score or total Persistent % of Gadolinium subdermally over total Persistent % of Gadolinium intramuscularly on MRI.
Other Names:
|
|
Experimental: Frontal
Frontal Gadolinium Magnevist® (gadopentetate dimeglumine) .1cc/ diluted with .9ccNS intramuscularly for 30 patients, and subdermally with ASIS Device for 30 patients. |
Gadolinium .1cc/
diluted with .9ccNS
intramuscularly with ASIS Device for 30 patients.
Total cumulative Persistent % of Gadolinium intramuscularly on MRI at 6 hrs, 12 hrs, and 24 hrs.
Other Names:
Relative Prolongation Ability Score or total Persistent % of Gadolinium subdermally over total Persistent % of Gadolinium intramuscularly on MRI.
Other Names:
|
|
Experimental: Temporal
Temporal Gadolinium Magnevist® (gadopentetate dimeglumine) .1cc/ diluted with .9ccNS intramuscularly for 30 patients, and subdermally with ASIS Device for 30 patients. |
Gadolinium .1cc/
diluted with .9ccNS
intramuscularly with ASIS Device for 30 patients.
Total cumulative Persistent % of Gadolinium intramuscularly on MRI at 6 hrs, 12 hrs, and 24 hrs.
Other Names:
Relative Prolongation Ability Score or total Persistent % of Gadolinium subdermally over total Persistent % of Gadolinium intramuscularly on MRI.
Other Names:
|
|
Experimental: Occipital
Occipital Gadolinium Magnevist® (gadopentetate dimeglumine) .1cc/ diluted with .9ccNS intramuscularly for 30 patients, and subdermally with ASIS Device for 30 patients. |
Gadolinium .1cc/
diluted with .9ccNS
intramuscularly with ASIS Device for 30 patients.
Total cumulative Persistent % of Gadolinium intramuscularly on MRI at 6 hrs, 12 hrs, and 24 hrs.
Other Names:
Relative Prolongation Ability Score or total Persistent % of Gadolinium subdermally over total Persistent % of Gadolinium intramuscularly on MRI.
Other Names:
|
|
Experimental: Paraspinal
Paraspinal Gadolinium Magnevist® (gadopentetate dimeglumine) .1cc/ diluted with .9ccNS intramuscularly for 30 patients, and subdermally with ASIS Device for 30 patients. |
Gadolinium .1cc/
diluted with .9ccNS
intramuscularly with ASIS Device for 30 patients.
Total cumulative Persistent % of Gadolinium intramuscularly on MRI at 6 hrs, 12 hrs, and 24 hrs.
Other Names:
Relative Prolongation Ability Score or total Persistent % of Gadolinium subdermally over total Persistent % of Gadolinium intramuscularly on MRI.
Other Names:
|
|
Experimental: Trapezius
Trapezius Gadolinium Magnevist® (gadopentetate dimeglumine) .1cc/ diluted with .9ccNS intramuscularly for 30 patients, and subdermally with ASIS Device for 30 patients. |
Gadolinium .1cc/
diluted with .9ccNS
intramuscularly with ASIS Device for 30 patients.
Total cumulative Persistent % of Gadolinium intramuscularly on MRI at 6 hrs, 12 hrs, and 24 hrs.
Other Names:
Relative Prolongation Ability Score or total Persistent % of Gadolinium subdermally over total Persistent % of Gadolinium intramuscularly on MRI.
Other Names:
|
|
Experimental: Change in frequency of headache days
Change in frequency of headache days as Efficacy of Botox intramuscularly at Week 6, Efficacy of Botox intramuscularly at Week 12, Efficacy of Botox intramuscularly at Week 18, Efficacy of Botox intramuscularly at Week 24, and Efficacy of Botox intramuscularly at Week 30 vs.Efficacy of Botox subdermally at Week 6, Efficacy of Botox subdermally at Week 12, Efficacy of Botox subdermally at Week 18, Efficacy of Botox subdermally at Week 24, and Efficacy of Botox subdermally at Week 30.
|
Efficacy of Botox (onabotulinumtoxinA) intramuscularly at Week 6, in terms of Change in frequency of headache days, and Change in hrs of HA on HA days.
Other Names:
Efficacy of Botox (onabotulinumtoxinA) intramuscularly at Week 12, in terms of Change in frequency of headache days, and Change in hrs of HA on HA days.
Other Names:
Efficacy of Botox (onabotulinumtoxinA) intramuscularly at Week 18, in terms of Change in frequency of headache days, and Change in hrs of HA on HA days.
Other Names:
Efficacy of Botox (onabotulinumtoxinA) intramuscularly at Week 24, in terms of Change in frequency of headache days, and Change in hrs of HA on HA days.
Other Names:
Efficacy of Botox (onabotulinumtoxinA) intramuscularly at Week 30, in terms of Change in frequency of headache days, and Change in hrs of HA on HA days.
Other Names:
Efficacy of Botox (onabotulinumtoxinA) subdermally at Week 6, in terms of Change in frequency of headache days, and Change in hrs of HA on HA days.
Other Names:
Efficacy of Botox (onabotulinumtoxinA) subdermally at Week 12, in terms of Change in frequency of headache days, and Change in hrs of HA on HA days.
Other Names:
Efficacy of Botox (onabotulinumtoxinA) subdermally at Week 18, in terms of Change in frequency of headache days, and Change in hrs of HA on HA days.
Other Names:
Efficacy of Botox (onabotulinumtoxinA) subdermally at Week 24, in terms of Change in frequency of headache days, and Change in hrs of HA on HA days.
Other Names:
Efficacy of Botox (onabotulinumtoxinA) subdermally at Week 30, in terms of Change in frequency of headache days, and Change in hrs of HA on HA days.
Other Names:
|
|
Experimental: Change in hrs of HA on HA days
Change in hrs of HA on HA days as Efficacy of Botox intramuscularly at Week 6, Efficacy of Botox intramuscularly at Week 12, Efficacy of Botox intramuscularly at Week 18, Efficacy of Botox intramuscularly at Week 24, and Efficacy of Botox intramuscularly at Week 30 vs.Efficacy of Botox subdermally at Week 6, Efficacy of Botox subdermally at Week 12, Efficacy of Botox subdermally at Week 18, Efficacy of Botox subdermally at Week 24, and Efficacy of Botox subdermally at Week 30.
|
Efficacy of Botox (onabotulinumtoxinA) intramuscularly at Week 6, in terms of Change in frequency of headache days, and Change in hrs of HA on HA days.
Other Names:
Efficacy of Botox (onabotulinumtoxinA) intramuscularly at Week 12, in terms of Change in frequency of headache days, and Change in hrs of HA on HA days.
Other Names:
Efficacy of Botox (onabotulinumtoxinA) intramuscularly at Week 18, in terms of Change in frequency of headache days, and Change in hrs of HA on HA days.
Other Names:
Efficacy of Botox (onabotulinumtoxinA) intramuscularly at Week 24, in terms of Change in frequency of headache days, and Change in hrs of HA on HA days.
Other Names:
Efficacy of Botox (onabotulinumtoxinA) intramuscularly at Week 30, in terms of Change in frequency of headache days, and Change in hrs of HA on HA days.
Other Names:
Efficacy of Botox (onabotulinumtoxinA) subdermally at Week 6, in terms of Change in frequency of headache days, and Change in hrs of HA on HA days.
Other Names:
Efficacy of Botox (onabotulinumtoxinA) subdermally at Week 12, in terms of Change in frequency of headache days, and Change in hrs of HA on HA days.
Other Names:
Efficacy of Botox (onabotulinumtoxinA) subdermally at Week 18, in terms of Change in frequency of headache days, and Change in hrs of HA on HA days.
Other Names:
Efficacy of Botox (onabotulinumtoxinA) subdermally at Week 24, in terms of Change in frequency of headache days, and Change in hrs of HA on HA days.
Other Names:
Efficacy of Botox (onabotulinumtoxinA) subdermally at Week 30, in terms of Change in frequency of headache days, and Change in hrs of HA on HA days.
Other Names:
|
|
Experimental: Adverse Reactions with Facial paresis
Facial paresis as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30.
|
Adverse Reactions of Botox (onabotulinumtoxinA) intramuscularly at Week 30, in number of Headache Migraine, Facial paresis, Eyelid ptosis, Bronchitis, Neck pain Musculoskeletal stiffness, Muscular weakness Myalgia, Musculoskeletal pain, Muscle spasms, Injection site pain, and Hypertension.
Other Names:
Adverse Reactions of Botox (onabotulinumtoxinA) subdermally at Week 30, in number of Headache Migraine, Facial paresis, Eyelid ptosis, Bronchitis, Neck pain Musculoskeletal stiffness, Muscular weakness Myalgia, Musculoskeletal pain, Muscle spasms, Injection site pain, and Hypertension.
Other Names:
|
|
Experimental: Adverse Reactions with Eyelid ptosis
Eyelid ptosis as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30.
|
Adverse Reactions of Botox (onabotulinumtoxinA) intramuscularly at Week 30, in number of Headache Migraine, Facial paresis, Eyelid ptosis, Bronchitis, Neck pain Musculoskeletal stiffness, Muscular weakness Myalgia, Musculoskeletal pain, Muscle spasms, Injection site pain, and Hypertension.
Other Names:
Adverse Reactions of Botox (onabotulinumtoxinA) subdermally at Week 30, in number of Headache Migraine, Facial paresis, Eyelid ptosis, Bronchitis, Neck pain Musculoskeletal stiffness, Muscular weakness Myalgia, Musculoskeletal pain, Muscle spasms, Injection site pain, and Hypertension.
Other Names:
|
|
Experimental: Adverse Reactions with Bronchitis
Bronchitis as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30.
|
Adverse Reactions of Botox (onabotulinumtoxinA) intramuscularly at Week 30, in number of Headache Migraine, Facial paresis, Eyelid ptosis, Bronchitis, Neck pain Musculoskeletal stiffness, Muscular weakness Myalgia, Musculoskeletal pain, Muscle spasms, Injection site pain, and Hypertension.
Other Names:
Adverse Reactions of Botox (onabotulinumtoxinA) subdermally at Week 30, in number of Headache Migraine, Facial paresis, Eyelid ptosis, Bronchitis, Neck pain Musculoskeletal stiffness, Muscular weakness Myalgia, Musculoskeletal pain, Muscle spasms, Injection site pain, and Hypertension.
Other Names:
|
|
Experimental: Adverse Reactions with Neck pain
Neck pain as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30.
|
Adverse Reactions of Botox (onabotulinumtoxinA) intramuscularly at Week 30, in number of Headache Migraine, Facial paresis, Eyelid ptosis, Bronchitis, Neck pain Musculoskeletal stiffness, Muscular weakness Myalgia, Musculoskeletal pain, Muscle spasms, Injection site pain, and Hypertension.
Other Names:
Adverse Reactions of Botox (onabotulinumtoxinA) subdermally at Week 30, in number of Headache Migraine, Facial paresis, Eyelid ptosis, Bronchitis, Neck pain Musculoskeletal stiffness, Muscular weakness Myalgia, Musculoskeletal pain, Muscle spasms, Injection site pain, and Hypertension.
Other Names:
|
|
Experimental: Adverse Reactions with Muscle stiffness
Musculoskeletal stiffness as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30.
|
Adverse Reactions of Botox (onabotulinumtoxinA) intramuscularly at Week 30, in number of Headache Migraine, Facial paresis, Eyelid ptosis, Bronchitis, Neck pain Musculoskeletal stiffness, Muscular weakness Myalgia, Musculoskeletal pain, Muscle spasms, Injection site pain, and Hypertension.
Other Names:
Adverse Reactions of Botox (onabotulinumtoxinA) subdermally at Week 30, in number of Headache Migraine, Facial paresis, Eyelid ptosis, Bronchitis, Neck pain Musculoskeletal stiffness, Muscular weakness Myalgia, Musculoskeletal pain, Muscle spasms, Injection site pain, and Hypertension.
Other Names:
|
|
Experimental: Adverse Reactions with Muscular weakness
Muscular weakness as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30.
|
Adverse Reactions of Botox (onabotulinumtoxinA) intramuscularly at Week 30, in number of Headache Migraine, Facial paresis, Eyelid ptosis, Bronchitis, Neck pain Musculoskeletal stiffness, Muscular weakness Myalgia, Musculoskeletal pain, Muscle spasms, Injection site pain, and Hypertension.
Other Names:
Adverse Reactions of Botox (onabotulinumtoxinA) subdermally at Week 30, in number of Headache Migraine, Facial paresis, Eyelid ptosis, Bronchitis, Neck pain Musculoskeletal stiffness, Muscular weakness Myalgia, Musculoskeletal pain, Muscle spasms, Injection site pain, and Hypertension.
Other Names:
|
|
Experimental: Adverse Reactions with Myalgia
Myalgia as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30.
|
Adverse Reactions of Botox (onabotulinumtoxinA) intramuscularly at Week 30, in number of Headache Migraine, Facial paresis, Eyelid ptosis, Bronchitis, Neck pain Musculoskeletal stiffness, Muscular weakness Myalgia, Musculoskeletal pain, Muscle spasms, Injection site pain, and Hypertension.
Other Names:
Adverse Reactions of Botox (onabotulinumtoxinA) subdermally at Week 30, in number of Headache Migraine, Facial paresis, Eyelid ptosis, Bronchitis, Neck pain Musculoskeletal stiffness, Muscular weakness Myalgia, Musculoskeletal pain, Muscle spasms, Injection site pain, and Hypertension.
Other Names:
|
|
Experimental: Adverse Reactions with Muscle pain
Musculoskeletal pain as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30.
|
Adverse Reactions of Botox (onabotulinumtoxinA) intramuscularly at Week 30, in number of Headache Migraine, Facial paresis, Eyelid ptosis, Bronchitis, Neck pain Musculoskeletal stiffness, Muscular weakness Myalgia, Musculoskeletal pain, Muscle spasms, Injection site pain, and Hypertension.
Other Names:
Adverse Reactions of Botox (onabotulinumtoxinA) subdermally at Week 30, in number of Headache Migraine, Facial paresis, Eyelid ptosis, Bronchitis, Neck pain Musculoskeletal stiffness, Muscular weakness Myalgia, Musculoskeletal pain, Muscle spasms, Injection site pain, and Hypertension.
Other Names:
|
|
Experimental: Adverse Reactions with Muscle spasms
Muscle spasms as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30.
|
Adverse Reactions of Botox (onabotulinumtoxinA) intramuscularly at Week 30, in number of Headache Migraine, Facial paresis, Eyelid ptosis, Bronchitis, Neck pain Musculoskeletal stiffness, Muscular weakness Myalgia, Musculoskeletal pain, Muscle spasms, Injection site pain, and Hypertension.
Other Names:
Adverse Reactions of Botox (onabotulinumtoxinA) subdermally at Week 30, in number of Headache Migraine, Facial paresis, Eyelid ptosis, Bronchitis, Neck pain Musculoskeletal stiffness, Muscular weakness Myalgia, Musculoskeletal pain, Muscle spasms, Injection site pain, and Hypertension.
Other Names:
|
|
Experimental: Adverse Reactions Injection site pain
Injection site pain as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30.
|
Adverse Reactions of Botox (onabotulinumtoxinA) intramuscularly at Week 30, in number of Headache Migraine, Facial paresis, Eyelid ptosis, Bronchitis, Neck pain Musculoskeletal stiffness, Muscular weakness Myalgia, Musculoskeletal pain, Muscle spasms, Injection site pain, and Hypertension.
Other Names:
Adverse Reactions of Botox (onabotulinumtoxinA) subdermally at Week 30, in number of Headache Migraine, Facial paresis, Eyelid ptosis, Bronchitis, Neck pain Musculoskeletal stiffness, Muscular weakness Myalgia, Musculoskeletal pain, Muscle spasms, Injection site pain, and Hypertension.
Other Names:
|
|
Experimental: Adverse Reactions with Hypertension
Hypertension as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30.
|
Adverse Reactions of Botox (onabotulinumtoxinA) intramuscularly at Week 30, in number of Headache Migraine, Facial paresis, Eyelid ptosis, Bronchitis, Neck pain Musculoskeletal stiffness, Muscular weakness Myalgia, Musculoskeletal pain, Muscle spasms, Injection site pain, and Hypertension.
Other Names:
Adverse Reactions of Botox (onabotulinumtoxinA) subdermally at Week 30, in number of Headache Migraine, Facial paresis, Eyelid ptosis, Bronchitis, Neck pain Musculoskeletal stiffness, Muscular weakness Myalgia, Musculoskeletal pain, Muscle spasms, Injection site pain, and Hypertension.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Relative Prolongation Ability Score for Gadolinium subdermally injected.
Time Frame: 12 months
|
Gadolinium will be injected with ASIS subdermally (30) or conventional intramuscularly (30) in Chronic Migraine adult patients for these 6 muscle groups: Glabella, Frontal, Temporal, Occipital, Paraspinal, and Trapezius.
An MRI will be taken promptly after Gadolinium injection, as starting reference, to which subsequent MRI taken at 6 hrs, 12 hrs, and 24 hrs later will be compared for Persistent %.
This approximation can only work if the variables are minimized to the same population with Chronic Migraine, and these particular 6 muscle groups.
The Relative Prolongation Ability Score or total Persistent % subdermally over total Persistent % intramuscularly, in Chronic Migraine patients will not be like those of normal patients, or even the same between these 6 different muscle groups, but valuable indicators to help us modify Botox dosage and duration to inject into "unknown" subdermal bloodless space for Aim 2.
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Efficacy of Botox intramuscularly vs. subdermally in Chronic Migraine.
Time Frame: 12 months
|
Efficacy of Botox intramuscularly vs. subdermally with ASIS Device at Week 6,12,18, 24, and 30; in terms of Change from baseline in frequency of headache days, and Change from baseline in total cumulative hours of headache on headache days.
|
12 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Adverse Reactions of Botox intramuscularly vs. subdermally in Chronic Migraine.
Time Frame: 12 months
|
Adverse Reactions of Botox intramuscularly vs. subdermally: Headache Migraine, Facial paresis, Eyelid ptosis, Bronchitis, Neck pain Musculoskeletal stiffness, Muscular weakness Myalgia, Musculoskeletal pain, Muscle spasms, Injection site pain, and Hypertension. |
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Bartleson JD, Cutrer FM. Migraine update. Diagnosis and treatment. Minn Med. 2010 May;93(5):36-41.
- Lorenc ZP, Kenkel JM, Fagien S, Hirmand H, Nestor MS, Sclafani AP, Sykes JM, Waldorf HA. A review of onabotulinumtoxinA (Botox). Aesthet Surg J. 2013 Mar;33(1 Suppl):9S-12S. doi: 10.1177/1090820X12474629.
- Knopp MV, Balzer T, Esser M, Kashanian FK, Paul P, Niendorf HP. Assessment of utilization and pharmacovigilance based on spontaneous adverse event reporting of gadopentetate dimeglumine as a magnetic resonance contrast agent after 45 million administrations and 15 years of clinical use. Invest Radiol. 2006 Jun;41(6):491-9. doi: 10.1097/01.rli.0000209657.16115.42. Erratum In: Invest Radiol. 2006 Sep;41(9):667.
- Montagna P. Migraine genetics. Expert Rev Neurother. 2008 Sep;8(9):1321-30. doi: 10.1586/14737175.8.9.1321.
- Robbins MS, Lipton RB. The epidemiology of primary headache disorders. Semin Neurol. 2010 Apr;30(2):107-19. doi: 10.1055/s-0030-1249220. Epub 2010 Mar 29.
- Levy D, Strassman AM, Burstein R. A critical view on the role of migraine triggers in the genesis of migraine pain. Headache. 2009 Jun;49(6):953-7. doi: 10.1111/j.1526-4610.2009.01444.x.
- Cousins G, Hijazze S, Van de Laar FA, Fahey T. Diagnostic accuracy of the ID Migraine: a systematic review and meta-analysis. Headache. 2011 Jul-Aug;51(7):1140-8. doi: 10.1111/j.1526-4610.2011.01916.x. Epub 2011 Jun 7.
- Olesen J, Burstein R, Ashina M, Tfelt-Hansen P. Origin of pain in migraine: evidence for peripheral sensitisation. Lancet Neurol. 2009 Jul;8(7):679-90. doi: 10.1016/S1474-4422(09)70090-0.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2016
Primary Completion (Anticipated)
June 1, 2016
Study Completion (Anticipated)
June 1, 2017
Study Registration Dates
First Submitted
February 26, 2014
First Submitted That Met QC Criteria
February 26, 2014
First Posted (Estimate)
February 28, 2014
Study Record Updates
Last Update Posted (Estimate)
June 24, 2015
Last Update Submitted That Met QC Criteria
June 22, 2015
Last Verified
June 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Headache Disorders, Primary
- Headache Disorders
- Migraine Disorders
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Cholinergic Agents
- Membrane Transport Modulators
- Acetylcholine Release Inhibitors
- Neuromuscular Agents
- Botulinum Toxins, Type A
- abobotulinumtoxinA
Other Study ID Numbers
- NCTNS088800
- R01NS088800 (Other Grant/Funding Number: NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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University Hospital, GrenobleGuerbetTerminated
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National Center for Research Resources (NCRR)University of PennsylvaniaUnknownMultiple SclerosisUnited States
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University Hospital, MontpellierSociété Française de CardiologieTerminatedAcute STEMI | Severe Left Ventricular Systolic Dysfunction (Disorder)France
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Rennes University HospitalBayerTerminatedMultiple Sclerosis (MS) | Inflammatory DiseaseFrance
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Massachusetts General HospitalWithdrawn
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Pharmacyclics LLC.CompletedLymphoma | Leukemia | Chronic Lymphocytic Leukemia | Small Lymphocytic LymphomaUnited States
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Pharmacyclics LLC.CompletedKidney Neoplasms | Carcinoma, Renal Cell | Urologic Neoplasms | Urogenital NeoplasmsUnited States